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2003D-0206:
Draft Guidance for Industry on Exocrine Pancreatic Insufficiency
Drug Products; Availability
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 04/27/2004
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| 04/27/2004
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| Federal
Government
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| Guideline
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| pdf
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| Signature:
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| Guideline
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| NAD1
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| 04/27/2004
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| FDA
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| FDA
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| 04/28/2004
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| 23414-23414
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| 06/28/2004
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 05/19/2004
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| 05/18/2004
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| Health Professional
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| Women and Children's
Hospital of Buffalo
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| htm
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| Signature:
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| Borowitz, Drucy
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| C1
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| pdf
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| Signature:
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| Tibor Sipos, PhD
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| C2
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Solvay Pharmaceuticals
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| pdf
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| Signature:
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| Edwin O. Billips
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| C3
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| 06/29/2004
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| 06/28/2004
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| Private Industry
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| CanReg, Inc.
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| pdf
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| Signature:
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| Subha Indrarajah,M.Sc., RAC
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| C4
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| 06/29/2004
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| 06/28/2004
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| Drug Industry
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| KV Pharmaceutical
Company
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| pdf
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| Signature:
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| Herbert G. Luther, PhD
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| C5
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| 06/28/2004
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| 06/28/2004
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| Private Industry
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| Ropes & Gray,
LLP
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| pdf
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| Signature:
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| Gregory J. Glover
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| C6
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| 06/28/2004
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| 06/22/2004
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| Drug Industry
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| Scientific Protein
Laboratories, LLC
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| pdf
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| Signature:
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| Christine E. Kois
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| C7
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| 06/28/2004
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| 06/25/2004
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| International Industry
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| Eurand S.p.A.
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| pdf
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| Signature:
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| Massimo Latino
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| C8
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| 06/30/2004
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| 06/28/2004
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| International Industry
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| Meristem Therapeutics
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| pdf
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| Signature:
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| Jean-Paul Rohmer
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| EC2
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC3
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC4
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC5
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC6
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC7
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, Tibor
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| EC8
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| pdf
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| Signature:
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| Sipos, Tibor
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| EC9
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care, Inc.
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| htm
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| Signature:
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| Sipos, T.
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Top | Up
Page last updated
September 21, 2005
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